USFDA Issues Form 483 to Torrent Pharma - 5 Observations
By Rediff Money Desk, New Delhi Jun 12, 2024 22:25
Torrent Pharmaceuticals received a Form 483 with five observations from the USFDA after an inspection of its Gujarat manufacturing plant. The company will respond to the observations within the prescribed timeframe.
![USFDA Issues Form 483 to Torrent Pharma - 5 Observations](https://im.rediff.com/money/2020/nov/15drug.jpg)
New Delhi, Jun 12 (PTI) Torrent Pharmaceuticals on Wednesday said the US health regulator has issued a Form 483 with five observations after inspecting its Gujarat-based manufacturing plant.
The US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) and a GMP inspection at the company's manufacturing facility in Indrad, Gujarat, from June 3 to June 12, the drug firm said in a regulatory filing.
At the end of the inspection, the company was issued a Form 483 with five observations, it added.
There is no observation related to data integrity reported, Torrent Pharma said.
"We will respond to the USFDA within the prescribed time frame and will work in close collaboration with the agency to address the observations at the earliest possible time," it stated.
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) and a GMP inspection at the company's manufacturing facility in Indrad, Gujarat, from June 3 to June 12, the drug firm said in a regulatory filing.
At the end of the inspection, the company was issued a Form 483 with five observations, it added.
There is no observation related to data integrity reported, Torrent Pharma said.
"We will respond to the USFDA within the prescribed time frame and will work in close collaboration with the agency to address the observations at the earliest possible time," it stated.
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Source: PTI
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
You May Like To Read
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- GTL Infrastructure
- 2.93 ( -4.87)
- 226206286
- IFL Enterprises
- 1.30 (+ 4.84)
- 81461564
- Vodafone Idea L
- 16.79 (+ 0.66)
- 67447398
- NCL Research
- 0.95 ( -4.04)
- 31996628
- Franklin Industries
- 3.73 (+ 3.32)
- 21511209
MORE NEWS
![Navi Mumbai...](https://im.rediff.com/80-80/money/2021/jun/10navi-mumbai-airport7.jpg)
Navi Mumbai Airport ILS Signal Testing Begins
The Airports Authority of India (AAI) has begun ILS signal testing at the...
![Air India VRS for...](https://im.rediff.com/80-80/money/2020/sep/09tata-vistara-3.jpg)
Air India VRS for Non-Flying Staff Ahead of...
Air India has announced a voluntary retirement scheme (VRS) and voluntary separation...
Fisher Groups Oppose WTO Fisheries Subsidy Talks
Small-scale fisher groups from India, Indonesia, and Bangladesh demand WTO keep...